Safety Alerts & Recalls

What does this mean?

The benefits of treatment with Procoralan (ivabradine) continue to outweigh the risks for most patients. If you have been prescribed Procoralan, you should continue to take it as directed. It is important that you do not stop taking Procoralan unless told to do so by a healthcare professional.

Procoralan has been linked to a potential increased risk of heart attack and stroke in some patients when their heat beat rate falls below a certain level. Doctors can take a number of measures to reduce this risk, including checking heart beat rate, drug dose, and other drugs taken at the same time. If you are taking Procoralan and experience any symptoms that could indicate a slow heart beat rate (such as dizziness or unusual tiredness) you should contact your doctor for advice.

If you have any questions about this alert or your treatment with Procoralan you should discuss them with your doctor or healthcare professional.

Procoralan Linked to Potential Risk of Heart Attack and Stroke in Patients with Slow Heart Beat

Servier Laboratories has written to healthcare professionals to advise them of emerging findings from clinical trials which suggest that patients taking Procoralan (ivabradine) who have a heart rate of less than 60 beats per minute (bpm) may be at an increased risk of experiencing a heart attack or stroke. To reduce this risk, healthcare professionals are reminded of a number of measures that should be taken, including: • Treatment with Procoralan should be stopped if resting heart beat falls below 60 bpm.

• The usual recommended starting dose of Procoralan is 5mg twice daily and the maintenance dose should not exceed 7.5mg twice daily.

• Patients should be monitored for signs of a low heart rate, and if this occurs the dose should be decreased.

• Procoralan should not be prescribed with calcium channel blocking drugs that reduce the heart rate, such as verapamil or diltiazem.

Procoralan is used to treat angina and heart failure.

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Source: MHRA
Publication Date: 2014-07-02
Last Updated: 2014-07-02

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